ID

42276

Beschrijving

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

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  1. 27-04-21 27-04-21 -
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GlaxoSmithKline

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27 april 2021

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Creative Commons BY 4.0
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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

Engels

Concomitant Medication; Adverse Experiences (Non-serious); Course Conclusion

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug Name
Beschrijving

Trade Name Preferred

Datatype

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

float

Alias
UMLS CUI [1]
C2348070
Administration Route
Beschrijving

Administration Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Beschrijving

Medical Condition

Datatype

text

Alias
UMLS CUI [1]
C0012634
Medication Start Date
Beschrijving

be as precise as possible

Datatype

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Beschrijving

Medication End Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Medication continuing?
Beschrijving

Medication continuing?

Datatype

integer

Alias
UMLS CUI [1]
C2826666
Adverse Experiences (Non-serious)
Beschrijving

Adverse Experiences (Non-serious)

Alias
UMLS CUI-1
C1518404
If no adverse experiences occured during the study, please sign form below and mark this box
Beschrijving

If no adverse experiences occured during the study, please sign form below and mark this box

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1298908
Adverse Experiences (Non-serious)
Beschrijving

Adverse Experiences (Non-serious)

Alias
UMLS CUI-1
C1518404
Adverse Experience
Beschrijving

Adverse Experience

Datatype

text

Alias
UMLS CUI [1]
C0877248
Adverse Experience Onset Date and Time
Beschrijving

Adverse Experience Onset Date and Time

Datatype

datetime

Alias
UMLS CUI [1]
C2985916
UMLS CUI [2]
C2697889
Adverse Experience End Date and Time
Beschrijving

If ongoing please leave blank

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Adverse Experience Outcome
Beschrijving

If patient died, STOP: go to SAE section and follow instructions given there

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Beschrijving

Experience Course

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If Intermittent Course, record number of episodes
Beschrijving

If Intermittent Course, record number of episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0205267
UMLS CUI [1,3]
C4086638
Common Toxicity Grade
Beschrijving

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening

Datatype

integer

Alias
UMLS CUI [1]
C2826262
Action Taken with Respect to Investigational Drug
Beschrijving

Action Taken with Respect to Investigational Drug

Datatype

integer

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Beschrijving

Relationship to Investigational Drug

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Beschrijving

If "Yes" record details in the Concomitant Medication section

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Beschrijving

Was patient withdrawn due to this specific AE?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Investigator's Signature (Adverse Experience)
Beschrijving

Investigator's Signature (Adverse Experience)

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0877248
Investigator's Signature
Beschrijving

Investigator's Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Beschrijving

Investigator's Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Course Conclusion
Beschrijving

Course Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Is the patient continuing to the next course of treatment?
Beschrijving

If "No", complete Best Overall Response Assessment, Study conclusion and Investigator's Signature on the next page. If "Yes", complete Investigator's Signature, but do NOT complete Best Overaall Response Assessment or Study Conclusion on the next page.

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Has the patient completed the study as planned?
Beschrijving

If "No" please mark the one most appropriate category.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205197
Reason for Withdrawal
Beschrijving

Reason for Withdrawal

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Other reason for withdrawal
Beschrijving

Other reason for withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
Comments on reason for withdrawal
Beschrijving

Comments on reason for withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0392360
Date of Last Study Evaluation
Beschrijving

Date of Last Study Evaluation

Datatype

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
Investigator's Signature (Study Conclusion)
Beschrijving

Investigator's Signature (Study Conclusion)

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0444496
Investigator's Signature
Beschrijving

I certify that I have reviewed the data on this Case Report Form and that all information is complete and accurate.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Beschrijving

Investigator's Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Concomitant Medication; Adverse Experiences (Non-serious); Course Conclusion

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Administration Route
Code List
Administration Route
CL Item
by mouth (PO)
CL Item
intravenous (IV)
CL Item
intramuscular (IM)
CL Item
intra-arterial (IAR)
CL Item
topical (TO)
CL Item
sublingual (SL)
CL Item
intrathecal (IT)
CL Item
vaginal (VA)
CL Item
nasal (NA)
CL Item
intra-articular injection (IA)
CL Item
transdermal (TD)
CL Item
inhaled (IH)
CL Item
subcutaneous (SC)
CL Item
rectal (PR)
CL Item
intradermal (ID)
Medical Condition
Item
Medical Condition
text
C0012634 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
Item
Medication continuing?
integer
C2826666 (UMLS CUI [1])
Medication continuing?
Code List
Medication continuing?
CL Item
Medication continuing (1)
Item Group
Adverse Experiences (Non-serious)
C1518404 (UMLS CUI-1)
Item
If no adverse experiences occured during the study, please sign form below and mark this box
integer
C0877248 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
If no adverse experiences occured during the study, please sign form below and mark this box
Code List
If no adverse experiences occured during the study, please sign form below and mark this box
CL Item
No Adverse Experience (1)
Item Group
Adverse Experiences (Non-serious)
C1518404 (UMLS CUI-1)
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Adverse Experience Onset Date and Time
Item
Adverse Experience Onset Date and Time
datetime
C2985916 (UMLS CUI [1])
C2697889 (UMLS CUI [2])
Adverse Experience End Date and Time
Item
Adverse Experience End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Experience Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Experience Outcome
Code List
Adverse Experience Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience Course
CL Item
Intermittent (1)
CL Item
Constant (2)
If Intermittent Course, record number of episodes
Item
If Intermittent Course, record number of episodes
integer
C0750729 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Common Toxicity Grade
Item
Common Toxicity Grade
integer
C2826262 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug stopped (4)
CL Item
Drug interrupted/ restarted (5)
CL Item
Dose dealyed (6)
CL Item
Dose delayed and decreased (7)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Not related (4)
CL Item
Unlikely (3)
CL Item
Suspected (reasonable possibility) (2)
CL Item
Probable (1)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient withdrawn due to this specific AE?
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
Investigator's Signature (Adverse Experience)
C2346576 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Course Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Is the patient continuing to the next course of treatment?
Item
Is the patient continuing to the next course of treatment?
boolean
C2348568 (UMLS CUI [1])
Has the patient completed the study as planned?
Item
Has the patient completed the study as planned?
boolean
C2348568 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Reason for Withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for Withdrawal
Code List
Reason for Withdrawal
CL Item
Adverse Experience (complete Adverse Experience section) (1)
CL Item
Lack of efficacy (2)
CL Item
Deviation from protocol (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other, Please specify (5)
Other reason for withdrawal
Item
Other reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Comments on reason for withdrawal
Item
Comments on reason for withdrawal
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Date of Last Study Evaluation
Item
Date of Last Study Evaluation
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Item Group
Investigator's Signature (Study Conclusion)
C2346576 (UMLS CUI-1)
C0444496 (UMLS CUI-2)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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